Medical Device Control Division , Thai - Food and Drug Administration,
is an organization which regulates and monitors Quality, Standard,
Efficiency and Safety of medical devices manufactured, imported
and sold in Thailand abide by Medical Device Act B.E. 2531 ( A.D.
1988 ), Ministerial Regulation and Notice of The Ministry of Public
Health

Currently, Medical devices in Thailand are classified into 3 groups
by following :I. Licence Medical devices - In this group of medical device,
all related entrepreneurs(i.e. manufacturer, importer and seller
) must have their medical devices approved to get licence by Thai
- Food and Drug Administration prior to making business in Thailand
comply to Ministerial Regulation No. 1 - 3 (B.E. 2533) . Licence
Medical devices must follow the quality and standard stated in related
Notice of The Ministry of Public Health comprising of
CONDOM
EXAMINATION GLOVE
SURGICAL GLOVE
HYPODEMIC SYRINGE
INSULIN SYRINGE
HIV TEST KIT ( for diagnostic use )
In addition, Licensee must follow to section 29-32 of Medical Device
Act B.E. 2531 ( A.D. 1988 ) and Ministerial Regulation No

III. General Medical devices - This group of medical device
is excluded from group I and group II. Only Importer must submit
certificate of freesale which
is issued by Government or approval private organization to get
approval by Thai- Food and Drug Administration in order to manifest
at Customs process following to Notice
of The Ministry of Public Health No. 6 ( B.E. 2532 )